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| Name | Class |
|---|---|
| Jurong Community Hospital, Singapore | UNKNOWN |
| Roceso Technologies | UNKNOWN |
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This proposed research aims to assess the efficacy and feasibility of the EsoGLOVE in the inpatient rehabilitation setting. 1. Understanding the ability of the EsoGLOVE in providing exercise and assisting stroke patients with completing hand functional tasks, eventually improves patients' motor function and neural recovery.2. To generate evidence on this innovative device and further deploy it in clinical practice. A Health Technology Assessment (HTA) will be generated from this study to evaluate the cost-effectiveness of the intervention.
This project proposes a study of 130 subjects in inpatient settings who have sustained their first-ever stroke prior to clinical trial enrolment. Participants are randomly assigned to 2 groups (EsoGLOVE group and GRASP group). The randomization method: A block randomization with a randomly varying block size. The study will last 12 weeks (3 weeks of intervention during hospitalization + 12th-week outpatient follow-up post-discharge). The subjects will use the study device about 15 times and be followed up for 3 weeks during hospitalization.
The subjects will need to visit the doctor's office 1 time (outpatient follow-up post-discharge) in the course of the study.During the hospitalization, the stroke patients (subjects) will receive intensive stroke rehabilitation as per normal, which will be daily physiotherapy and occupational therapy as a part of standard care as per stroke rehabilitation. On top of the standard care (daily Inpatient OT Rehabilitation), the EsoGLOVE subjects will receive EsoGLOVE training on therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a minimum of 30 minutes per day. While the GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day.In the case of early discharge or withdrawal for any reason before the 3-week intervention is completed, the subjects will no longer participate in this study and no study-related activities will be performed on the subjects. The subjects' right to receive standard care will remain the same as per hospital guidelines and will not be affected. This is applicable to both groups. With minimal compliance rate (10 sessions) for continuing the study, regardless of the subjects' discharge before 3 weeks, otherwise (less than or equal to 9 sessions) subjects will be withdrawn at the day of discharge or withdrawal. The 12th-week outpatient follow-up post-discharge at the clinic will coincide with the subject's standard care follow-up visit.The Health Technology Assessment (HTA) is conducted by the study team using explicit analytical frameworks, clinical outcomes, epidemiological data amp; statistics, health economic information, and study methodology. The assessment includes building evidence on the qualities and costs of health interventions (cost-effectiveness), identifying the direct amp; indirect medical costs in the current healthcare system, capturing the clinical outcomes of interventions, synthesizing health research findings of the effectiveness of different health interventions, evaluating the economic implications and analyzing the cost-effectiveness of the intervention.It is unlikely this study might unintentionally come to know of new information (Incidental Finding) about the health condition from the assessment (Fugl-Meyer Assessment - Upper Extremity) of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EsoGLOVE | Experimental | The EsoGLOVEGroup subjects will receive EsoGLOVE training on therapy day for 3 weeks (week 1 to week 3, sessions will be done every Monday to Friday), a minimum of 30 minutes per day |
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| Graded Repetitive Arm Supplementary Program (GRASP) Group | Active Comparator | The GRASP group subjects will receive the Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EsoGLOVE | Device | The dose is referred to the stay of inpatient setting. The stroke patients will be transferred to community hospital when medically stable. The average of stay in community hospital is 3 weeks. The stroke patients will receive intensive stroke rehabilitation during the stay, which will be daily physiotherapy and occupational therapy. The subjects will receive EsoGLOVE training on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day, up to 15 sessions. This is similar to the dose in a similar trial (DSRB 2017/00312, Robotic Sock Technology for Prevention of Deep Vein Thrombosis and Joint Contracture). |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment - Upper Extremity (FMA-UE) | To achieve minimum of 5 in FMA-UE difference/change between treatments and pre & post intervention (3th - 0th week). | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pui Kit Tam, MBBS | Alexandra Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandra Hospital | Singapore | Singapore | ||||
| Jurong Community Hospital |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Graded Repetitive Arm Supplementary Program (GRASP) | Other | Graded Repetitive Arm Supplementary Program (GRASP) on therapy day (Monday to Friday) for 3 weeks, a minimum of 30 minutes per day. |
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| Singapore |
| Singapore |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |